Actively Recruiting
Impact of Beta Blockers on TAVI (BETA-TAVI)
Led by National and Kapodistrian University of Athens · Updated on 2024-12-09
347
Participants Needed
2
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicentre, investigator-initiated, randomized clinical trial clinical trial investigating the impact of beta-blockers administration among patients undergoing TAVI for severe aortic valve stenosis. Adults already receiving beta-blockers be assigned randomly in 1:1 ratio to either continue or withdraw the beta-blockers medication at least 72 hours before and at least 7 days after TAVI. The primary endpoint is permanent pacemaker implantation rates in 7 days after the procedure. Secondary endpoints include death, cardiogenic shock and arrhythmias/conduction abmormalities with time frame 12 months.
CONDITIONS
Official Title
Impact of Beta Blockers on TAVI (BETA-TAVI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years old or older
- Severe symptomatic aortic stenosis defined by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area < 1 cm2 or indexed aortic valve area to body surface area < 0.6 cm2/m2
- High risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team
- Anatomic suitability for TAVI based on local Heart Team decision
- Currently receiving beta-blockers as part of treatment
- Understands the trial purpose, risks, and benefits and willing to participate in follow-up
- Provided written consent to participate
You will not qualify if you...
- Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, titanium, nickel, cobalt, chromium, or contrast media
- Presence of a permanent pacemaker or defibrillator
- Ongoing infection including active endocarditis
- Echocardiographic evidence of left ventricular or left atrial thrombus
- Contraindication for antithrombotic treatment
- Estimated life expectancy less than 12 months
- Pregnancy or pre-perimenopause
- Second or third degree atrioventricular block
- Bradycardia (heart rate less than 50 beats per minute) at screening
- Co-morbidity that excludes or significantly interferes with follow-up visits
- Enrolled in another study that interferes with this trial
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Nicosia General Hospital
Nicosia, Cyprus
Actively Recruiting
2
First Department of Cardiology, National and Kapodistrian University of Athens
Athens, Attica, Greece, 11527
Actively Recruiting
Research Team
L
Leonidas Koliastasis, MD, MSc, PhD
CONTACT
O
Odysseas Katsaros, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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